Страна: Велика Британія
мова: англійська
Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fentanyl
Pfizer Ltd
N02AB03
Fentanyl
25microgram/1hour
Transdermal patch
Transdermal
Schedule 2 (CD)
Valid as a prescribable product
BNF: 04070200; GTIN: 5013457011029
OPIODUR 25 MICROGRAMS/HOUR TRANSDERMAL PATCH Summary of Product Characteristics Updated 03-Aug-2016 | Pfizer Limited 1. Name of the medicinal product Opiodur 25 micrograms/hour transdermal patch 2. Qualitative and quantitative composition Each Opiodur 25 micrograms/ hour transdermal patch contains 2.75 mg of fentanyl in a patch size of 10cm 2 , releasing 25 micrograms of fentanyl per hour. Excipients(s) with known effect: For the full list of excipients, see section 6.1. 3. Pharmaceutical form Transdermal Patch Opiodur transdermal patch is a rectangular, tan coloured patch placed between two oversized, transparent protective layers which must be removed prior to the patch application. The patches will be imprinted: Fentanyl 25 μg/h in red ink 4. Clinical particulars 4.1 Therapeutic indications ADULTS This product is indicated in severe chronic pain which can be adequately managed only with opioid analgesics. CHILDREN Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age. 4.2 Posology and method of administration It is not possible to ensure the interchangeability of different fentanyl containing transdermal patch product in individual patients. Therefore, it should be emphasised that patients should not be changed from one fentanyl containing product to another without specific counselling on the change from their healthcare professionals. Initial dose selection The appropriate initiating dose of fentanyl should be based on the patient's current opioid use. It is recommended that fentanyl be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance. ADULTS Opioid-tolerant patients To convert opioid-tolerant patients from oral or parenteral opioids to fentanyl refer to _Equianalgesic _ _potency conversion_ below. The dosage may subsequently be titrated upwards or downwards, if Прочитайте повний документ